MAUDE Adverse Event Report: ABBOTT VASCULAR DRAGONFLY OPSTAR¿ IMAGING CATHETER; DIAGNOSTIC IMAGING CATHETER

Catalog Number 1014652

Device Problems Break (1069); Obstruction of Flow (2423); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/10/2022

Event Type  malfunction  

Manufacturer Narrative

Visual, functional, and dimensional analysis was performed on the returned device.The reported obstruction of flow could not be confirmed, and the reported break/rupture at the purge port could not be confirmed; however, a leak was noted at the proximal region of the sheath.Further investigation revealed that the sheath appeared to have a rupture, resulting in a gap, from which the aforementioned leak was noted.The cause of the leak is consistent with the sheath damage.Functional testing could not be confirmed due to the device condition.Dimensional inspection revealed the purge hole inner diameter met the specifications.A review of the lot history record identified no exception issue for this lot related to reported issue.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.The investigation was unable to determine the cause of the leak finding at the proximal region of the sheath.Although the cause of the sheath damage could not be determined, it may be possible that over-pressurization during flushing the device contributed the sheath damage; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that during device preparation, when the dragonfly opstar was purged with contrast using a 3cc syringe, the syringe was unable to be pressed.While pressing the syringe harder, the purge port ruptured.No patient was involved with this device.Another catheter was used to complete the procedure with no adverse patient consequences.There was no clinically significant delay.No additional information was provided.Return device analysis identified a longitudinal tear on the sheath.

• Brand Name: DRAGONFLY OPSTAR¿ IMAGING CATHETER
• Type of Device: DIAGNOSTIC IMAGING CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT MEDICAL REG#3009600098; 4 robbins rd; westford MA 01886
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 14459416
• MDR Text Key: 292724750
• Report Number: 2024168-2022-05447
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K192019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/17/2023
• Device Catalogue Number: 1014652
• Device Lot Number: 8035687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1